Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

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Humoral immune response in terms of neutralizing antibodies [ Time Frame: at Days 0, 21, 42, 182 and 364 ]

Occurrence of solicited local and general symptoms [ Time Frame: During the 7-day follow-up period after each vaccination. ]

Occurrence of unsolicited adverse events [ Time Frame: Within 21 days after the first vaccination (Day 0 - Day 20) and up to 63 days after the second vaccination for the two groups with two vaccination doses (Day 21 - Day 83) ]

Occurrence of potential Immune-Mediated-Diseases [ Time Frame: During the entire study period (up to Day 364). ]

Occurrence of serious adverse events [ Time Frame: During the entire study period (up to Day 364). ]

Humoral immune response in terms of neutralizing antibodies [ Time Frame: at Days 0, 21, 42, 182 and 364 ]

Occurrence of solicited local and general symptoms [ Time Frame: During the 7-day follow-up period after each vaccination. ]

Occurrence of unsolicited adverse events [ Time Frame: Within 21 days after the first vaccination (Day 0 - Day 20) and up to 63 days after the second vaccination for the two groups with two vaccination doses (Day 21 - Day 83) ]

Occurrence of serious adverse events [ Time Frame: During the entire study period (up to Day 364). ]

Occurrence of potential Immune-Mediated-Diseases [ Time Frame: During the entire study period (up to Day 364). ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

Official Title ICMJE

Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.

A male or female aged 18 to 60 years of age at the time of the first vaccination.

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

Written informed consent obtained from the subject.

Satisfactory baseline medical assessment by history and physical examination.

Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.

Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.

Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

Presence of an axillary temperature >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

Any contraindication to intramuscular administration of the influenza vaccines.

An acute evolving neurological disorder or history of Guillain-Barré syndrome.

Administration of any vaccines within 30 days before vaccination.

Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

Pregnant or lactating female

Female planning to become pregnant or planning to discontinue contraceptive precautions.

Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ICMJE

NCT00992511

Other Study ID Numbers ICMJE

113809

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Yes

Plan Description:

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.